Safety Study of FSME-IMMUN NEW in Healthy Children and Adolescents Aged 1 to 15 Years

Tick-borne Encephalitis Clinical Trial

Official title:

Open-label Safety Study of FSME-IMMUN NEW in Healthy Children and Adolescents Aged 1 to 15 Years

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00161863
• Other study ID #: 209
• Status: Completed
• Phase: Phase 3
• First received: September 8, 2005
• Last updated: May 20, 2015
• Start date: September 2002
• Est. completion date: January 2003

Study information

• Verified date: May 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the safety of five consecutive lots of FSME-IMMUN NEW in healthy volunteers. The main criterion for investigation is the fever rate after the first vaccination in three different age classes. The immunogenicity of 0.25 ml FSME-IMMUN NEW has been demonstrated in previous clinical studies in children; therefore, in the present study, immunogenicity was investigated in a subgroup only.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: January 2003
• Gender: Both
• Age group: 1 Year to 15 Years

Eligibility

Inclusion Criteria:

Male and female children and adolescents will be eligible for participation in this study if:

• they are aged 1 year (from the 1st birthday) to < 16 years (to the last day before the 16th birthday);

• they are clinically healthy, (i. e. the physician would have no reservations vaccinating with FSME-IMMUN NEW outside the scope of a clinical trial);

• their parents/legal guardians understand the nature of the study and agree to its provisions;

• written informed consent is available from both parents/legal guardians,

• for Germany/Austria: additional written informed consent is available for children older than 8 years

• they or their parents/legal guardians agree to keep a volunteer diary.

For safety reasons, female volunteers who have reached sexual maturity at study start have to meet the following additional inclusion criteria:

• negative pregnancy test at study entry;

Exclusion Criteria:

Children and adolescents will be excluded from participation in this study if they:

• have a history of any TBE vaccination;

• have a history of TBE infection;

• have a history of allergic reactions to one of the components of the vaccine;

• suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids, chemotherapeutics) that can be expected to influence immunological functions;

• are known to be HIV positive (a special HIV test is not required for the purpose of the study);

• have received banked blood or immunoglobulins within one month of study entry;

• have a history of vaccination against yellow fever and/or Japanese B-encephalitis;

• suffer from hemorrhagic diathesis;

• are participating simultaneously in another clinical trial;

• if female: are pregnant or breastfeeding.

Volunteers who meet the inclusion/exclusion criteria, but have a febrile illness (body temperature > 38°C) at the scheduled time of vaccination, will not be vaccinated before their body temperature returns to normal.

Volunteers who have received any other vaccination within 4 weeks prior to visit 1 will not be vaccinated until an interval of 4 weeks has passed. In this case visit 1 will take place separately.

If volunteers have received antipyretics within 4 hours prior to the intended TBE vaccination, the vaccination should be performed at a later time.

Volunteers who have a positive TBE antibody value prior to the first vaccination will be excluded from the statistical analysis of the primary endpoint.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Encephalitis
• Encephalitis, Tick-Borne
• Tick-borne Encephalitis

Intervention

Biological:
• FSME-IMMUN NEW 0.25 ml

Locations

Country	Name	City	State
Austria	Grieskirchner Strasse 17	Wels
Germany	Marktplatz 3	Bad Saulgau
Germany	Solothurner Strasse 2	Heilbronn
Germany	Hauptstraße 240	Kehl
Poland	Wojewodzki Szpital Dziececy oddz. Obserwacyjno-Zakazny	Kielce
Poland	Szpital Jana Pawla II Odz. Neuroinfekcji	Krakow
Poland	Samodzielny Publiczny ZOZ Oddzial Dzieciecy	Lubartow
Poland	PANTAMED sp.z.o.o.	Olsztyn

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

Austria,  Germany,  Poland,